FDA The article describes in detail the mechanisms to be used by the authority to provide its feedback regarding the device development. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Asia The new article highlights additional aspects related to the change notification process, including the turn-around time and fees. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
FDA The new article highlights specific aspects related to the entrance review, the ones the authority will also assess when determining the eligibility of the product and application associated thereto for review under the appropriate framework. ...
Asia The new article describes in detail the approach to be applied by a party responsible for a medical device when notifying the regulating authority about the changes to the product already placed on the market. Table of Contents The Health...
FDA The new article addresses the aspects related to the factors for Safer Technologies Program (STeP) entrance and review process. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
